The present invention relates to a member and method for anchoring and relieving the strain on a percutaneous lead and, more particularly, to a member and method for anchoring and relieving the strain on a flexible, conductive percutaneous lead where the lead exits the body of a patient.
Various flexible, percutaneous leads, have been employed in the past which extend into the body of a patient and exit the patient's body at some selected location on the body. Such leads, for example, may include electrically conductive temporary or permanent heart pacer leads or neural stimulator leads for stimulating the nervous system of the patient. One end of such lead, the end in the patient's body, is located at the location which is to be stimulated, for example the myocardium or in the epidural space surrounding the spinal cord. The conductive lead exits the body at a conveniently selected location and the other end of the lead is connected to a stimulator which may be carried on the exterior of the patient's body. The stimulator produces electrical signals which are transmitted through the lead to stimulate the tissue which is to be stimulated deep within the patient's body.
In the past, such percutaneous leads have been fixed in place at the location at which the lead exits the body by sutures in the skin at that location. Such suturing method of fixation has several disadvantages. One disadvantage is that strains which may be imparted to the lead during patient activity are transmitted to the sutured exit location and may cause movement or displacement of the lead and tearing of the skin by the sutures with attendant trauma to the patient. Another disadvantage is that the sutured exit is subject to infection, not only due to exposure of the sutures and lead(s) themselves, but also as a result of displacement of the lead due to strains which may be imparted to the lead and the sutures at the lead exit location during patient activity. Another disadvantage is the need for the sutures themselves, which are subject to infection, which may produce trauma, and which may result in puncturing of the insulation on the lead during placement of or strain on the sutures.
A member and method for anchoring and relieving the strain on such leads incorporating the principles of the present invention substantially reduces the likelihood of the occurrence of these disadvantageous consequences. A member and method incorporating the principles of the present invention firmly anchors and stabilizes the lead against movement at its exit location from the body during activity of the patient, thus substantially reducing the possibility of displacement of the lead or of infection or trauma resulting from such displacement and movement. The member and method incorporating the principles of the present invention also covers the lead exit to protect the exit against contamination which could lead to infection. The member and method incorporating the principles of the present invention is both simple to use, install and remove, and is inexpensive. The member and method incorporating the principles of the present invention firmly anchors the lead and may, in many cases, reduce, if not eliminate the need altogether for sutures for closure of the exit and the attendant disadvantages of such sutures.
In one principal aspect of the present invention, a member for anchoring and relieving the strain on a flexible, percutaneous lead which exits the body of a patient comprises a flexible disc having a first surface for contacting and conforming to the body of the patient at the location at which the lead exits the body, and a second surface opposite the first surface. An adhesive is located on the first surface for adhering the disc and its first surface to the body at the location at which the lead exits the body and over substantially the entire area of the first surface. A passage of substantially constant cross-section over its length extends through the thickness of the disc and opens through the first and second surfaces, the substantially constant cross-section being sized to snugly receive a lead which is also of substantially constant cross-section and such that the constant cross-section of the lead may be slidably positioned in the passage to extend beyond the first and second surfaces.
In another principal aspect of the present invention, the aforesaid member includes a bulbous shaped head projecting from the second surface of the disc and the passage extends into and opens through this head.
In still another principal aspect of the present invention, the aforementioned members may also include a slit through the disc extending from the perimeter of the disc to the passage, whereby the disc may be opened to be positioned around the head.
In still another principal aspect of the present invention, a method of anchoring and relieving the strain on a flexible, percutaneous lead which exits the body of a patient comprises positioning one end of the lead through the skin of the patient, positioning the portion of the lead which exits the patient's body to extend snugly through a passage through the thickness of a flexible disc such that the lead extends from both sides of the disc, shaping a surface of the disc to conform to the patient's body and positioning the surface against the body at the location where the lead exits the patient's body, and adhesively bonding the surface to the patient's body at the last mentioned location to anchor the disc and lead thereto.
In still another principal aspect of the present invention, the aforementioned method includes the disc having a bulbous shaped head projecting from a surface of the disc opposite the last mentioned surface, with the passage also extending into and opening through the head. The lead is positioned to extend through the passage in the head and is secured in the passage by binding a flexible thread means around the stem portion of the bulbous shaped head.
In still another principal aspect of the present invention, the aforementioned methods also include the disc having a slit extending from the perimeter of the disc to the passage, and the lead is positioned in the passage by opening the disc at the slit and sliding the lead through the open slit to the passage.
These and other objects, features and advantages of the present invention will be clearly understood through a consideration of the following detailed description.